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FDA 510(k)

RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL

K-Number: K880794 · 1988-04-18

ApplicantTrace America, Inc.
Decision Date1988-04-18
Product CodeKHS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL is the device name listed in this FDA 510(k) record. The listed applicant is Trace America, Inc.. It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K880794. The device is classified under product code KHS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL?

RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Trace America, Inc.. The 510(k) number is K880794.

When did RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL receive FDA 510(k) clearance?

RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL received FDA 510(k) clearance on 1988-04-18, under 510(k) number K880794.

Who is the listed applicant for RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL?

The FDA 510(k) record lists Trace America, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL?

The FDA product code for RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL is KHS.

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Other records listing Trace America, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K003583LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901K980026GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K980030AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)K973869TRACE REAGENT LINE FOR THE COBAS MIRAK974620AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)

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Related Devices (Code: KHS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K170200Carbon Dioxide Reagent SetTeco Diagnostics, Inc.K152085Liquid CO2-2 (LCO2-2)Randox Laboratories, Ltd.K131546AU BICARBONATE REAGENTBeckman Coulter Ireland, Inc.K123953ACE CARBON DIOXIDE REAGENT, ACE DIRECT BILIUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K120765VITROS CHEMISTRY PRODUCTS ECO2 SLIDESOrtho-Clinical Diagnostics, Inc.K113435ACE CARBON DIOXIDE(CO2-LC) REAGENT, ACE DIRECT BILIRUBIN REAGENT, ACE TOTAL BILIRUBIN REAGENT, ACE MAGNESIUM REAGENTAlfa Wassermann

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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